Heart Failure; With DecompensationNCT02134379
Dynamic Thoracic Impedance as a Marker for Heart Failure Decompensation
An observational study of Heart Failure; With Decompensation, run by Charles Porter, MD at 1 site in United States.
Trial summary
This pilot study proposes to perform measurements of approved thoracic impedance technology that will help answer questions in patients with decompensated heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure; With Decompensation
- What is being tested?
- Medtronic ICDs, CRT-Ds, and CRT-Ps
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be identified from the KU Hospital Cardiology clinic.
Who may be able to join
- Patients with systolic dysfunction
- Able to provide informed consent
- Have a Medtronic manufactured device with Thoracic Impendence Monitoring capabilities
Who cannot join
- Patients with severe congestive heart failure who are intubated
- Patients who are oxygen dependent on continuous positive or bilevel positive ventilation
- Inability to tolerate postural variations due to congestive heart failure or other medical or surgical condition.Unable to complete proposed testing
- Subjects who cannot giveWill not give written, informed consent on their own behalf
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Dynamic Thoracic Impedance as a Marker for Heart Failure Decompensation: A Pilot Trial of the "Dynamic Thoracic Impedance Bed Rest Test"
This pilot study proposes to perform measurements of approved thoracic impedance technology that will help answer questions in patients with decompensated heart failure.
Read the detailed description
Improved metrics derived from the transthoracic impedance (Z) available from implanted Medtronic devices may provide more sensitive indicators of the state of compensation for heart failure patients. Quantification of specific data may provide new information that can improve quality of life for patients and offer vital information to clinicians regarding the adequacy of inpatient and outpatient assessment and management of acute decompensated heart failure.
- Conditions
- Heart Failure; With Decompensation
- Being tested
- Medtronic ICDs, CRT-Ds, and CRT-Ps
- Keywords
- Thoracic Impedance, Diagnostic Marker, Bed Rest Test, Transthoracic Impedance, Heart Failure, HF
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic ICDs, CRT-Ds, and CRT-PsDevice
Also called ICDs:, Evera(TM) XT DR (Models DDBB1D4, DDBB1D1), Evera(TM) XT VR (Models DVBB1D4, DVBB1D1), Protecta(R) XT DR (Models D314DRG, D314DRM)
Any Medtronic implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device. Device must have capacity to measure thoracic impedance as described in protocol. This includes the majority of FDA-approved Medtronic devices currently in use.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure | Subjects have implanted Medtronic device and a primary diagnosis of left ventricular systolic dysfunction Receives: Device: Medtronic ICDs, CRT-Ds, and CRT-Ps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from sitting to supine to standing in thoracic impedance
thoracic impedance will be measured at each position at baseline visit then again at the follow-up visits through 30 days
Measured: Baseline, 30 Days
Secondary outcomes (1)
Rate of change in thoracic impedance
Measured: Baseline, 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure; With DecompensationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Porter, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor-investigator, Charles Porter, MD, University of Kansas Medical Center
- Investigators
- Charles Porter, MD, FACC, FACP, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134379
- Sponsor's protocol ID
- STUDY00000596
- Status last verified
- Apr 2016
- First submitted
- 7 May 2014
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Thoracic Impedance as a Marker for Heart Failure Decompensation: A Pilot Trial of the "Dynamic Thoracic Impedance Bed Rest Test"
- ClinicalTrials.gov ID
- NCT02134379
- Acronym / sponsor ID
- STUDY00000596
- Conditions
- Heart Failure; With Decompensation
- Keywords
- Thoracic Impedance, Diagnostic Marker, Bed Rest Test, Transthoracic Impedance, Heart Failure, HF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Charles Porter, MDUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Apr 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 9 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study proposes to perform measurements of approved thoracic impedance technology that will help answer questions in patients with decompensated heart failure.
Detailed description
Improved metrics derived from the transthoracic impedance (Z) available from implanted Medtronic devices may provide more sensitive indicators of the state of compensation for heart failure patients. Quantification of specific data may provide new information that can improve quality of life for patients and offer vital information to clinicians regarding the adequacy of inpatient and outpatient assessment and management of acute decompensated heart failure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure | – | Device: Medtronic ICDs, CRT-Ds, and CRT-PsSubjects have implanted Medtronic device and a primary diagnosis of left ventricular systolic dysfunction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be identified from the KU Hospital Cardiology clinic.
Key inclusion criteria (3 listed)
- Patients with systolic dysfunction
- Able to provide informed consent
- Have a Medtronic manufactured device with Thoracic Impendence Monitoring capabilities
Key exclusion criteria (4 listed)
- Patients with severe congestive heart failure who are intubated
- Patients who are oxygen dependent on continuous positive or bilevel positive ventilation
- Inability to tolerate postural variations due to congestive heart failure or other medical or surgical condition.Unable to complete proposed testing
- Subjects who cannot giveWill not give written, informed consent on their own behalf
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic ICDs, CRT-Ds, and CRT-PsAlso: ICDs:, Evera(TM) XT DR (Models DDBB1D4, DDBB1D1), Evera(TM) XT VR (Models DVBB1D4, DVBB1D1), Protecta(R) XT DR (Models D314DRG, D314DRM)Any Medtronic implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device. Device must have capacity to measure thoracic impedance as described in protocol. This includes the majority of FDA-approved Medtronic devices currently in use. | Device | Heart Failure |
Primary outcome
Change from sitting to supine to standing in thoracic impedance
Time frame: Baseline, 30 Days
thoracic impedance will be measured at each position at baseline visit then again at the follow-up visits through 30 days
1 secondary outcome
Rate of change in thoracic impedance
Time frame: Baseline, 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Porter, MD, FACC, FACP principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure; With Decompensation, run by Charles Porter, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from sitting to supine to standing in thoracic impedance (time frame: Baseline, 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.